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Clinical Trials List

Protocol NumberIMMU-132-13
NCT Number(ClinicalTrials.gov Identfier)NCT04527991
Completed

2022-01-01 - 2024-07-31

Phase III

Recruiting11

ICD-10C68.9

Malignant neoplasm of urinary organ, unspecified

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9189.9

Malignant neoplasm of urinary organ, site unspecified

A Randomized Open-Label Phase III Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Subjects With Metastatic or Locally Advanced Unresectable Urothelial Cancer

  • Trial Applicant

    Pharmaceutical Research Associates Taiwan Inc.

  • Sponsor

    Gilead Sciences

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Chia-Chi Lin 無
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 鄭元佐 未分科
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hsi-Chin Wu Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hsiao-Jen Chung 無
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 夏和雄 未分科
Taipei Tzu Chi Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 呂長賢 無
Chiayi Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wen-Pin Su Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林仁泰 無
Kaohsiung Veterans General Hosptial

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 吳俊德 未分科
Chang Gung Medical Foundation Chang Gung Memorial Hospital, Keelung

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Cheng-Che Chen Division of Urology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Kai-Jie Yu 無
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Locally Advanced or Metastatic Unresectable Urothelial Cancer

Objectives

Primary Objective: To assess overall survival (OS) with sacituzumab govitecan in comparison with treatment of physician’s choice (TPC) in subjects with metastatic or locally advanced unresectable urothelial cancer (UC) Secondary Objectives: 1. To assess progression-free survival (PFS) with sacituzumab govitecan in comparison with TPC by investigator assessment and blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 2. To assess objective response rate (ORR), clinical benefit rate (CBR), and duration of objective tumor response (DOR) with sacituzumab govitecan in comparison with TPC by investigator assessment and BICR using RECIST v1.1 3. To assess safety and tolerability of sacituzumab govitecan in comparison with TPC 4. To assess Quality of Life (QOL) with sacituzumab govitecan in comparison with TPC Exploratory Objectives: 1. To assess and compare efficacy in a subset defined by tumor expression of Trop-2 and ascertain the role of expression of Trop-2 as a biomarker for response 2. To investigate candidate blood and tumor biomarkers as a biomarker for response 3. To investigate potential correlation between serum sacituzumab govitecan pharmacokinetics (PK) and the development of immunogenicity (ADA) 4. To characterize the PK of sacituzumab govitecan in metastatic UC subjects

Test Drug

Sacituzumab Govitecan

Active Ingredient

Sacituzumab Govitecan

Dosage Form

Powder for Concentrate for Solution for Infusion

Dosage

180 mg

Endpoints

Overall Survival (OS)

Inclution Criteria

如果您在篩選/治療的第 1 療程第 1 天 (Cycle 1 Day 1，C1D1) 時符合下列所有納入條件，
您將符合資格參加本試驗。
1. ≥18 歲的女性或男性受試者，能夠了解並簽署書面受試者同意書。(在臺灣只會收納至少
20 歲的受試者。)
2. 受試者患有經組織學方法證實之轉移性或局部晚期無法切除的泌尿上皮癌 (urothelial
cancer，UC)，其定義為：
• 腫瘤 (tumor，T) 4b、任何結節 (node，N) 或
• 任何 T、N 2 至 3
允許有上或下泌尿道的腫瘤。如果泌尿上皮是主要組織學類型，則允許有混合組織學類
型。
3. 美國東岸癌症研究合作小組 (Eastern Cooperative Oncology Group，ECOG) 體能狀態
(performance status，PS) 分數為 0 或 1 分。
4. 將收納在接受含鉑療程及抗 PD-1/PD-L1 療法治療轉移性或局部晚期無法切除之疾病
後，惡化或復發的受試者。
a. 在新輔助性/輔助性情境下完成所給予含 Cisplatin 的化學治療後，於 12 個月 (含)
內復發或惡化的受試者，可利用該線療法來符合參加試驗的資格。12 個月期間是
分別從完成手術介入或含鉑療法起計算。這些受試者必須在轉移性或局部晚期無法
切除的情況下接受抗 PD-1/PD-L1 療法，才符合資格。
b. 在新輔助性/輔助性情境下接受 Carboplatin 或抗 PD-1/PD-L1 療法的受試者，無法
將該線療法計入參加試驗的資格。
c. 不符合 Cisplatin 使用資格而符合下列其中一項條件的受試者，以及在轉移性或局
部晚期無法切除的情境下接受 Carboplatin 治療的受試者，可將該線療法計入資
格。這些受試者必須接著在轉移性或局部晚期無法切除的情境下接受抗 PD-1/PDL1 療法，才符合參加試驗的資格。
不符合 Cisplatin 使用資格的定義為符合下列其中一項條件：
i. 肌酸酐清除率 <60 mL/min
ii. ≥ 第 2 級聽力檢查的聽力喪失
iii. ≥ 第 2 級周邊神經病變
iv. 紐約心臟學會 (New York Heart Association，NYHA) 第 III 級心臟衰竭
v. ECOG PS ≥2
d. 維持療法中施用的抗 PD-1/PD-L1 療法可計入參加試驗的資格。
e. 為了保留膀胱僅接受同步化學放射療法、而未進一步接受全身性療法的受試者，將
不符合本試驗收納資格。如果療程中未加入新的化學治療藥劑，且在更換鉑之前未
發現有惡化，則以 Carboplatin 取代 Cisplatin 的情形並不構成新療程。
5. 先前接受過腦轉移治療的受試者，如果在接受第一劑試驗藥物前，具有穩定的中樞神經
系統 (central nervous system，CNS) 疾病持續至少 4 週，且所有神經學症狀均穩定，亦
沒有證據顯示有新增或增大的腦轉移，並在接受第一劑試驗藥物前至少 7 天並未因腦
轉移而使用類固醇 (每日 >20 mg 的 Prednisone [或等效藥物])，則可能參加試驗。
6. 在啟用試驗藥物的 1 週內有足夠的血液學計數，而不需要輸血或生長因子支持 (血紅
素 ≥9 g/dL、嗜中性白血球絕對計數 [absolute neutrophil count，ANC] ≥1,500/mm3 及血
小板 ≥100,000/µL)。
7. 足夠的肝功能 (膽紅素 ≤1.5 倍試驗機構正常值上限 [institutional upper limit of normal
，IULN]、天門冬胺酸轉胺酶 [aspartate aminotransferase，AST] 及丙胺酸轉胺酶
[alanine aminotransferase，ALT] ≤2.5 倍 IULN 或 ≤5 倍 IULN [如果已知肝轉移及血清
白蛋白 >3 g/dL])。
Docetaxel 僅適用於醫師選用治療 (treatment of physician’s choice，TPC) 組中總膽紅
素 ≤1 倍 IULN 和 AST 及/或 ALT ≤1.5 倍 IULN (如果鹼性磷酸酶亦 >2.5 倍
IULN) 的受試者。
8. 經 Cockcroft-Gault 公式或其他經確效工具 (例如腎臟病飲食調整 [Modification of Diet
in Renal Disease，MDRD] 公式) 評估之肌酸酐清除率 ≥30 mL/min。
9. 具有生育能力的女性受試者，必須在接受第一劑試驗藥物前 72 小時內具有陰性的尿液
或血清驗孕結果。如果尿液檢測呈陽性或無法確認為陰性，則需要進行血清驗孕。
10. 具有生育能力的女性受試者，必須願意在試驗過程中直到最後一劑試驗藥物後 6 個月
期間，使用 2 種避孕方法或透過手術絕育或避免與異性從事性行為。具有生育能力的
受試者是指未曾透過手術絕育或尚未停經 >2 年者。
11. 男性受試者必須同意從第一劑試驗療法開始、直到最後一劑試驗療法後 3 個月期間，
使用一種適當的避孕方法。如果您在篩選/治療的 C1D1 時符合下列任一項排除條件，將不會被收納於本試驗。

Exclusion Criteria

Subjects meeting any of the following exclusion criteria at Screening/C1D1 of treatment will not
be enrolled in the study:
1. Women who are pregnant or lactating.
2. Have had a prior anti-cancer mAb/ ADC within 4 weeks prior to C1D1 or have had prior
chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior
to C1D1. Subjects participating in observational studies are eligible.
3. Have received prior chemotherapy for UC with all available SOC therapies in the control
arm (i.e., both prior paclitaxel and docetaxel in regions where vinflunine is not an
approved therapy, or prior paclitaxel, docetaxel and vinflunine in regions where
vinflunine is an approved therapy).
4. Have not recovered (i.e., ≤Grade 1) from AEs due to previously administered
chemotherapeutic agent.
• Note: Subjects with ≤Grade 2 neuropathy or any grade of alopecia are an exception
to this criterion and will qualify for the study.
• Note: If subjects received major surgery, they must have recovered adequately from
the toxicity and/or complications from the intervention prior to starting study therapy.
5. Have previously received topoisomerase 1 inhibitors.
6. Have an active second malignancy.
• Note: Subjects with a history of malignancy that have been completely treated and
with no evidence of active cancer for 3 years prior to enrollment, or subjects with
surgically cured tumors with low risk of recurrence are allowed to enroll in the study
after discussion with the medical monitor.
7. Have active cardiac disease, defined as:
a. Myocardial infarction or unstable angina pectoris within 6 months of C1D1.
b. History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular
fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring
anti-arrhythmic medications (except for atrial fibrillation that is well controlled with
antiarrhythmic medication); history of QT interval prolongation.
c. NYHA Class III or greater congestive heart failure or left ventricular ejection fraction
of <40%.
8. Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease) or
gastrointestinal (GI) perforation within 6 months of enrollment.
9. Have an active serious infection requiring anti-infective therapy (Contact medical
monitor for clarification).
10. Have known history of Human Immunodeficiency Virus (HIV)-1/2 with undetectable
viral load and on medications that may interfere with SN-38 metabolism.
11. Have active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV). In subjects with a
history of HBV or HCV, subjects with a detectable viral load will be excluded.
12. Have other concurrent medical or psychiatric conditions that, in the investigator’s
opinion, may be likely to confound study interpretation or prevent completion of study
procedures and follow-up examinations.
13. Have inability to tolerate or are allergic to any potential TPC agent or sacituzumab
govitecan or unable or unwilling to receive the doses specified in the protocol.
14. Have inability to complete all specified study procedures for any reason.

The Estimated Number of Participants

  • Taiwan

    55 participants

  • Global

    709 participants

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